Safety lancet assembly

ABSTRACT

A lancet assembly comprising an elongated lancet and a plurality of cooperative members at least some of which are movable relative thereto so as to selectively orient the lancet in a covered position, operative position or protected position. The plurality of members each comprise at least one coded structure visually indicative of the lancet being in one of the aforementioned positions dependent at least in part on which one or more of the coded structures are predominantly observable. The coded structures may comprise color codings which may be visually distinguishable or visually indistinguishable from one another. Coded structures other than color codings may be utilized.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] This invention relates to a lancet assembly including a lancetcapable of being selectively disposed in any of a plurality of positionsand further including a coded structure associated with operativecomponents or members of the lancet assembly which are visuallyindicative of the position of the lancet.

[0003] 2. Description of the Related Art

[0004] Lancets have long been employed to pierce or prick a patient'sskin to provide a small outflow of blood that can be used in variousmedical tests. At least one conventional lancet device generallyincludes an elongated rod or shaft, generally defining the lancetitself, having a sharp sterile tip, a plastic retainer member moldeddirectly about the lancet and from which the sharp tip extendsoutwardly, and a removable cap connected to the plastic retainer memberand in which the sterile tip is encased to prevent contamination priorto use.

[0005] Lancets are used both at home by the patient or in medicaloffices and hospitals by health care professionals, and can be used toprick the patient's skin either by manual penetration or in conjunctionwith a mechanical device into which the lancet unit is installed andthen removed after use. In the home setting, most lancets are used bythe patient with the mechanical device, which is designed to acceptlancets of various sizes. In the medical office and hospital setting,lancets are often used manually in order to avoid the necessity ofhaving to re-sterilize the mechanical device after each use. After thelancet unit has been used to prick the patient's skin, either manuallyor by means of the mechanical device, the sharp lancet tip iscontaminated with the patient's blood. Because of the various high-risk,life-threatening diseases that are currently prevalent throughout theworld, used lancet units constitute an extremely hazardous form ofwaste. It is therefore essential that contaminated lancet tips becompletely and securely shielded upon disposal of the used lancet unitsto prevent others, such as sanitation employees who routinely areunknowingly exposed to such types of hazardous waste, from beingaccidentally jabbed.

[0006] Thus, when used in the home patients are typically advised todiscard used lancet units in a rigid container such as a coffee can ormilk carton. However, many patients frequently fail to follow suchadvice. In addition, although it is possible to dispose of a used lancetdevice, such as the type described above, by inserting the sharpcontaminated tip back into the cap which was removed prior to use, thisis generally not done. One reason for this is because the cap is fairlysmall and the hole in it is minuscule. Accordingly, the personattempting to recap the used lancet is exposed to the risk ofinadvertently jabbing himself with the contaminated lancet tip before itis finally inserted into the cap. Also, the cap can be lost or misplacedafter being removed from the lancet unit prior to use, therebyprecluding its replacement. Even if the lancet tip is replaced back intosuch a cap, however, there is a possibility that the cap canaccidentally fall or be knocked off because the cap is not designed tobe securely reconnected to the retaining member or the tip after thelancet has been used.

[0007] More recently, lancet units have been designed with protectivecaps that include a mouth, sized and adapted to fit securely over theend face of the lancet retainer member from which the tip extends, andpocket into which the tip of a used lancet can be inserted andprotectively enclosed. Although the enlarged mouth decreases thepossibility that a person may accidentally jab himself when replacingthis type of cap, the risk of such an occurrence still exists becausethe user's hand which grasps the cap is required to move in thedirection of the sharp lancet tip in order to re-cap the lancet unit.Thus, if the user becomes momentarily distracted from the task, forexample, the mouth of the cap may not be replaced precisely over the endface of the lancet retainer member and the user can still inadvertentlyjab himself with the contaminated lancet tip. In addition, a used lancetunit protected with such a cap might be mistaken for an unused unit.

[0008] In order to overcome the problems set forth above it would bedesirable to have a lancet assembly which includes a lancet having asharpened tip, and otherwise at least partially structured to include aplurality of components or members, operatively associated with thelancet. At least some of the plurality of members would be disposablerelative to the lancet and the sharpened tip in particular, such thatthe lancet could be oriented in anyone of a plurality of positions. Inorder to provide further protection of a user of such a preferred lancetassembly and at the same time provide a clear indication as to which ofthe plurality of positions the lancet is oriented, such an improvedlancet assembly could include a coded structure disposed on at leastsome of the plurality of members operatively associated therewith. Suchcoded structure could take a variety of different forms such as acolored coding, indicia or other structures.

[0009] Regardless of the specific embodiment, such a preferred codedstructure would provide a clear visual indication as to the position ororientation of the lancet. Moreover, such visual indication would bedetermined by the relative orientation or positions of the lancet aswell as the plurality of operative components or members relativethereto. An important feature of such an improved lancet assembly,including the aforementioned coded structure, would be to provide aclear visual indication to the user as to whether or not the lancet hadbeen previously used or not.

[0010] Therefore, such an improved lancet assembly would preferably bestructured to meet the needs of the individual as intended, whileeliminating certain risks to which the user may be normally exposed.

SUMMARY OF THE INVENTION

[0011] The present invention is directed to a single use lancet assemblywhich may be used either manually or with a mechanical device of thetype well known in the medical profession. It is emphasized that thelancet assembly may include a number of different structures and mayvary in size, overall configuration, etc. However, in the preferredembodiment of the present invention, the lancet assembly comprises alancet having a sharpened tip formed on one end thereof. The lancetassembly further includes a plurality of associated, cooperativelystructured components or members, at least some of which are disposablerelative to the lancet so as to define, with the lancet, the positioningthereof in one of a plurality of positions.

[0012] More specifically, the plurality of positions referred to hereininclude the lancet being disposed in an operative position and/or aprotected position being distinguishable by the sharpened tip of thelancet being oriented in an exposed or non-exposed positionrespectively. Further, the lancet assembly could include, as one of theaforementioned plurality of components or members, a cover member. Thecover member is removably disposed in overlying, covering relation tothe sharpened tip of the lancet, at least initially, prior to its use.Typically, the cover member will be oriented in such a covered positionwhen the lancet assembly is removed from the sterile packaging before itis applied to a patient.

[0013] In addition to the above, the plurality of associated membersfurther include a retaining member which is fixedly secured to thelancet and movable therewith. The retaining member may take a variety ofdifferent configurations but in one preferred embodiment it is fixedlysecured to the lancet at least adjacent one end thereof, so as to bemovable therewith. Also, the retaining member may extend along amajority or at least some of the length of the lancet, which typicallyincludes an elongated configuration. Further, the retaining member maybe structured and disposed to facilitate manual gripping or manipulationthereof so as to aid in the orientation of the lancet, relative to theother plurality of members. As such the lancet is easily disposed inanyone of the aforementioned covered position, protected position oroperative position.

[0014] The plurality of cooperative members further includes aprotective member which is movable relative to the lancet. Theprotective member includes an interior channel disposed and dimensionedto extend over the sharpened tip, such that the tip is disposed on theinterior of the protective member. The lancet and particularly thesharpened tip are thereby oriented in a non-exposed or protectedposition thereby providing assurance that the tip will not accidentallycontact or penetrate the user, patient or others.

[0015] The protective member further includes a coupling assembly formedat least partially thereon wherein the coupling assembly is structuredto lock or otherwise prevent the lancet in the protected position. Thelancet tip is thereby prevented from inadvertently or purposely beingdisposed outwardly from the interior of the protective member into anexposed orientation. The coupling assembly is structured toautomatically assume the locked orientation once the lancet is placed inthe protected position.

[0016] Accordingly, the lancet may be selectively disposed in thecovered position, operative position and protected position dependingupon the current step of the procedure in which the lancet is beingutilized. More specifically, and by way of example only, theaforementioned cover member will be disposed in overlying, coveringrelation to the sharpened tip of the lancet thereby defining the lancetin the covered position. The covered position will be assumed by thelancet when it is removed from the sterile packaging and immediatelyprior to its intended use. Once the use of the lancet, in its intendedfashion is imminent, the cover is removed from the covered positionthereby exposing the sharpened tip of the lancet.

[0017] The protective member is maintained in an initial position inwhich it is disposed when the lancet is removed from the originalpackaging. The sharpened tip extends outwardly from one end of theprotective member and is freely exposed for engagement with the patient,as intended. After use, the protective member is forced longitudinallyalong the length of the lancet such that the lancet passes into theinterior of the protective member so as to be enclosed. Theaforementioned coupling assembly is automatically engaged so that theprotective member can not be inadvertently or purposely moved to anorientation where the sharpened tip of the lancet is exposed.

[0018] In order to further assure the safety of the user and provide aclear indication as to the current position assumed by the lancet, apreferred embodiment of the present invention incorporates the provisionof coded structures disposed on at least some of the plurality ofcomponents or members. In at least one preferred embodiment the codedstructures are disposed on the cover member, retaining member,protective member and possibly the lancet itself. The physicalcharacteristics and location of the coded structures may vary greatlydepending upon the individual structural features of the lancet assemblywith which the aforementioned coded structures are utilized. It isemphasized that the coded structures of the present invention is notintended to be limited to any one lancet assembly but rather are capableof being utilized with a variety of differently structured lancetassemblies and still fall within the intended spirit and scope of thepresent invention.

[0019] In addition, at least one preferred embodiment of the presentinvention could define the coded structures as a plurality of colorcodings at least some of which are visually distinguishable from oneanother. The color codings could appear on all, or at least some of thecooperative plurality of members associated with the lancet assembly asindicated above. Alternatively, the coded structures of the presentinvention could comprise a variety of different indicia appearing on atleast some of the plurality of members. Further, some of the indiciawould be visually distinguishable from one another wherein others of theindicia would be substantially the same or substantially visuallyindistinguishable from one another.

[0020] Regardless of the specific structural embodiments of the codedstructures being utilized, the color codings, indicia, etc. which arepredominantly observable by a user, or others, would be visuallyindicative of the position in which the lancet and in particular thesharpened tip would be oriented. A change in the relative positions ororientations of the plurality of members including the cover member,retaining member, protective member and the lancet itself would providea different visual indication to the user due to the fact that differentones of the coded structures would be predominantly observable.

[0021] These and other objects, features and advantages of the presentinvention will become more clear when the drawings as well as thedetailed description are taken into consideration.

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] For a fuller understanding of the nature of the presentinvention, reference should be had to the following detailed descriptiontaken in connection with the accompanying drawings in which:

[0023]FIG. 1 is a longitudinal sectional view showing a lancet assemblyof the present invention in a covered position.

[0024]FIG. 2 is a longitudinal sectional view of the lancet assembly ofthe present invention including a cover member thereof removed and thelancet being disposed in an operative position.

[0025]FIG. 3 is a longitudinal sectional view of the lancet assembly ofthe present invention as it is being disposed from an operative positionof FIG. 2 into a protected position.

[0026]FIG. 4 is a longitudinal section view of the lancet assembly ofthe present invention disposed in the protected position.

[0027]FIG. 5 is a longitudinal sectional view of another preferredembodiment of the lancet assembly of the present invention disposed inan un-exposed operative position.

[0028]FIG. 6 is a longitudinal sectional view of the embodiment of FIG.5 wherein the lancet assembly is disposed in an exposed, operativeposition.

[0029] Like reference numerals refer to like parts throughout theseveral views of the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0030] As shown in the accompanying drawings, the present invention isdirected to a lancet assembly generally indicated as 10. The lancetassembly 10 includes a lancet 12 preferably having an elongatedconfiguration and a sharpened tip 14 formed on one end thereof. Thelancet 12 and tip 14 is used, in the conventional fashion, to prick orjab a patient's skin for purposes of obtaining a sample of blood.Depending upon the specific structural features and configuration of thelancet assembly 10, it comprises a plurality of associated components ormembers. The plurality of members cooperate with one another and withthe lancet 12 so as to allow the selective orientation of the lancet 12,and in particular the sharpened tip 14, into one of a plurality ofpositions.

[0031] For purposes of clarity and as will be explained in greaterdetail hereinafter, at least some of the plurality of positions aredefined in FIGS. 1, 2 and 4. More specifically, in the position of FIG.1, the lancet 12 and the tip 14 is disposed in a covered position. Theposition of FIG. 2 is that of an operative position, wherein the tip 14is exposed for engagement with the patient. It is emphasized thatdepending upon the specific structure and intended operation of a givenlancet assembly 10, positions of the lancet 12 and penetrating tip 14may be included, other than those set forth above.

[0032] Accordingly, the lancet assembly 10 and the aforementionedplurality of cooperative members include, in addition to the lancet 12,a cover member 16 having a somewhat hollow interior and a sleeve likeconfiguration terminating in an open end 18 and preferably a closed end20. The cover member 16 is disposed to slide over and frictionallyengage a protective member 22 as best shown in FIG. 1. A manual, pullingforce exerted on the cover member 16 in the direction indicated bydirectional arrow 23 will serve to easily remove the cover member 16from its covered position. In such covered position, penetrating tip 14is enclosed within the interior of the cover member 16 and is therebyprevented from inadvertently coming into contact with a user, patient orothers. Further, the cooperative orientation of the plurality ofcooperative components or members as shown in FIG. 1 may preferably bethe overall position and configuration which the lancet assembly 10 mayassume as it is removed from sterile packaging, immediately prior touse.

[0033] Additional structural features of the lancet assembly 10 includethe protective member 22 preferably including an outwardly extendingflange 24 which may have a substantially annular configuration as itextends radially outward from the outer surface of the protective member22. In addition, and as shown in FIG. 1, the flange 24 may be disposedbeyond the exterior surface of the cover 16 and may be dimensioned andconfigured to facilitate gripping and positioning of the protectivemember 22 relative to the lancet 12.

[0034] In addition, the plurality of members of the lancet assembly 10include a retaining member 26. The retaining member 26 is fixedlysecured to the lancet 12 at least along a portion of its length and atleast adjacent an end 13 which is oppositely disposed to the penetratingtip 14. The retaining member 26 has an inner portion 28 and an outer,barrel-like portion 30. An at least partially open space 32 is disposedthere between and may vary in both dimension and configuration,dependent at least in part on the size, disposition and configuration ofat least a portion of the protective member 22. The space 32 may have anannular configuration or be defined by separate spaced apart segmentedspaces.

[0035] In either of the aforementioned structures, or in any otherstructural equivalent thereto, the space 32 is dimensioned andconfigured to receive outwardly extending arm members 34 which arefixedly and/or integrally secured to the protective member 22. The armmembers 34 define at least a portion of a coupling assembly, the detailsof which will be explained in greater detail hereinafter. The one ormore arms 34 may vary in size, dimension, configuration and number andmay be spaced from one another as shown or may include an annular orsemi-annular skirt like structure. Each of the one or more arms 34includes a coupling head 36 formed at a free end thereof. The couplingheads 36 are intended to cooperate with grooves 38 and 38′ integrallyformed in the interior portion 28 of the retaining member 26. As suchthe grooves 38 and 38′ also comprise at least a portion of the of theaforementioned coupling member.

[0036] In at least one embodiment of the present invention anotherstructural feature of the retaining member 26 includes an elongatedsleeve or shaft 29 which extends along and substantially encloses aportion of the length of the lancet 12. The sleeve like shaft 29 may befixedly molded or otherwise integrally secured to the retaining member26 so as to extend along the interior thereof and more particularly theinterior of the inner portion 28. As will be more fully explainedhereinafter, the shaft 29 may therefore, in at least one preferredembodiment, be considered a part of the retaining member 26. However, asshown in the accompanying Figures the shaft 29 is dimensioned to extendalong most, if not all, of the lancet 12 accept, of course, for thepenetrating tip 14. Accordingly, the sleeve 29 may be considered a partof the lancet 12 rather than the retaining member 26, although itremains fixedly attached to the retaining member 26.

[0037] Accordingly, it is emphasized that whether the sleeve-like shaft29 is considered a part of the retaining member 26 or a part of thelancet 12, both structural variations are to be considered structuralequivalents in terms of the intended spirit and scope of the presentinvention. As such, the shaft 29 is clearly observable when the lancet12 is oriented in the protected position of FIG. 4 and non-observablewhen the lancet is oriented in the covered and operative positions ofFIGS. 1 and 2, respectively.

[0038] Further, as the lancet assembly 10 is removed from its sterilepackaging, the lancet is oriented in the covered position of FIG. 1, aslong as the cover member 16 remains in place. Once the lancet is readyfor use, the cover member 16 is removed by exerting the aforementionedforce in the direction indicated by directional arrow 23. The lancet 12and penetrating tip 14 thereby assumes the operative position as clearlydisclosed in FIG. 2.

[0039] In the operative position of the embodiment of FIG. 2, thepenetrating tip 14 extends outwardly from the opening 27 formed in anouter most end of an elongated channel 25 extending along the length ofthe retaining member 22. As shown, the protective member 22 is slidablymovable relative to at least a portion of the lancet 12 and the shaft 29as the are disposed within the channel 25. When the lancet assembly 10is in the operative position of FIG. 2 it may be applied to a patienteither manually or using a mechanical triggering mechanism, as set forthabove.

[0040] The operative position may further include the one or more arms34 and the corresponding coupling heads 36 engaging the retaining member26 and the slots or recesses 38. In such a position the arms 34 of theprotective member are substantially covered by the barrel or outerportion 30 of the retaining member 26 and therefore are not visuallyobservable by a user of the lancet assembly 10.

[0041] However, after contact with the patient it is important that thepenetrating tip 14 not be exposed so that inadvertent penetration orcontact with others may be prevented. Therefore, as shown in FIG. 3 theplurality of members associated with the lancet assembly 10 areselectively disposed, relative to one another and to the lancet 12 andpenetrating tip 14 so that the tip 14 is disposed in the protectedposition, as set forth above. In doing so the user of the lancetassembly 10 may grip or otherwise manually engage the outwardlyextending flange 24, or other portion of the protective member 22, andexert a force thereon in the direction indicated by directional arrow27. This will serve to disengage the coupling heads 36 from the slots 38and allow longitudinal travel of the protective member 22 outwardlyalong the length of the lancet 12 and the shaft 29 in enclosing relationto the penetrating tip 14.

[0042] With reference to FIG. 4, the protected position is therebydisclosed, wherein the penetrating tip 14 passes into the interior ofthe channel 25 extending within and along the length of the protectivemember 22. The penetrating tip 14 is disposed such that it does notextend outwardly through the open end 27 but is maintained on theinterior of the protective member 22 as shown. Further, the lancet 12and tip 14 are locked or secured in the protected position by virtue oflocked the orientation of the coupling assembly.

[0043] More specifically, the one or more arms 34 extend outwardly asthey slide along the interior space or opening 32 between the interiorportion 28 and barrel 30 of the retaining member However, once thecoupling heads 36 reach a position which coincides with a one or moreslots 38′, they are received therein. Due to the cooperativeconfiguring, dimensioning, etc. of the coupling heads 36 and thecorrespondingly positioned receiving slots 38′, the protective member 22is prevented from moving inwardly in the direction of arrow 31 of FIG.4. Therefore, it is extremely difficult, if not impossible to againexpose the penetrating tip 14 beyond the open end 25 of the protectivemember, once the lancet 12 is oriented in the aforementioned protectedposition of FIG. 4.

[0044] As indicated above, it is important that the operators, patientsand others associated with the use of the lancet assembly 10 beprotected from inadvertently coming into contact with the tip 14,particularly after the lancet assembly has been used in the intendedfashion. Also, it is believed to be equally important to provide a clearvisual indication as to the condition and/or position of the lancetassembly 10, particularly, but not exclusively, in terms of being readyfor use or having been previously used.

[0045] Accordingly, a feature of the various preferred embodiments ofthe present invention comprises a plurality of coded structures disposedon or directly associated with all or at least some of the plurality ofmembers which comprise the lancet assembly 10. As will be explained ingreater detail hereinafter the coded structures of one preferredembodiment of the present invention comprises a plurality of colorcodings disposed on the plurality of members. It is emphasized thatindicia other then color codings can define the coded structuresdisposed on each or at least some of the plurality of members of thelancet assembly 10. Such indicia can include any type of visuallydiscernable marking, design, display, alpha/numeric indicator or thelike. Further, for purposes of fully describing the coded structures,the term indicia may also encompass surface texturing or discernableconfiguring in a manner which allows one of the plurality of members, ora portion thereof to be distinguished, at least in part, from at leastone other of the plurality of members included in the lancet assembly10.

[0046] Therefore, in the preferred embodiment shown in the accompanyingFigures, the coded structures of the present invention is represented bya plurality of color codings. Moreover, various ones of the plurality ofmembers may include substantially the same color coding or a colorcoding which is substantially indistinguishable from color codings ofother of the plurality of members. Alternatively the color codings ofone or more of the plurality of members may be clearly distinguishablefrom color codings of others of the plurality of members. Accordingly,dependent on which of the color codings (or other indicia defining thecoded structures) are visually observable, and in certain instancespredominantly observable, the user or others associated with the use ofthe lancet assembly 10 are provided with a clear visual indication ofwhich of the plurality of positions the lancet 12 and the penetratingtip is disposed. Concurrently, a user is provided with a visualindication as to whether or not the lancet assembly 10′ is ready forinitial use or has already been used.

[0047] For purposes of clarity the color codings defining the codedstructure of the preferred embodiments of FIGS. 1 through 4 includes thevisually discernable colors green (G), yellow (Y) and red (R). However,it should be clear that any colors or combination of colors may be usedto define the color codings of the coded structures of the presentinvention. The colors green, yellow and red are used by way of exampleonly in order to further clarify the intended use and structure of thepresent invention. These colors are universally recognized as beingrepresentative of various conditions of use or readiness. For example,green is well recognized as being representative of a “safe” condition.Yellow is recognized as being representative of a condition of caution.Finally, red is universally recognized as an alert or danger condition.

[0048] Therefore, with primary reference to FIG. 1, the lancet assembly10 is in a covered position with the lancet 12 and particularly thepenetrating tip 14 being disposed within the interior of the covermember 16. As such, the predominantly observable color is green in thatthe coded structures of the various members comprise the cover memberbeing green, the majority and/or exterior portion of the retainingmember 26 also being green and the gripping flange 24 having a yellowcolor coding. Therefore, one associated with the use of the lancetassembly 10 would observe a predominantly green color indicatingsomewhat of a safe or unused condition of the lancet assembly 10.

[0049] With reference to FIG. 2, the lancet assembly 10 is disposed inan operative position, with the cover 16 being removed from theprotective member 22 and the tip 14 being exposed and ready for use. Thecolor coding defining the coded structure of the protective member 22 isyellow thereby indicating to an observer that a certain amount ofcaution must be exercised. In this operative position, yellow would bethe more predominantly observable color by those associated with the useof the lancet assembly 10. It is of course noted that the exposedportions of the barrel 30 and remainder of the retaining member 26 isgreen. However, the color coding of yellow, being the most recentlyexposed color coding and indicating a caution condition, would beconsidered the predominantly observable color as long as the lancet 12and the penetrating tip 14 are in the operative position of FIG. 2.

[0050] After use, including penetration of the tip 14 into an intendedpatient, the lancet assembly 10 and the various members thereof aremanipulated so as to dispose the lancet 12 and the penetrating tip 14into the aforementioned protected position. In doing so the flange 24 orother portion of the protective member 22 are gripped so as to move theprotective member in a direction indicated by directional arrow 27. Indoing so a space 50 will be created between the protective member 22 andthe retaining member 26. The space 50 will be sufficiently sized anddisposed in cooperative relation with the shaft 29 (whether the shaft 29is considered a part of the retaining member 26 or lancet 12) such thatthe shaft 29 can be visually observed.

[0051]FIG. 3 indicates an intermediate position as the protective member22 is being disposed into the protected position. As shown in FIG. 4 thelancet assembly 10 is fully oriented in the protected position and theopening or space 50 assumes its larger dimension. Space 50, therefore,allows for clear, visual observation of the shaft 29 which includes acolor coding of red as the defined coded structure thereon. In addition,another preferred embodiment of the lancet assembly 10 may include oneor more windows or openings 52 formed in the barrel 30. The windows 52are located so as to observe the interior space 32, the position of thearms 34 (Y) therein or alternatively the exposure of the inner portion28 (R) of the retaining member 26.

[0052] As disclosed in the various Figures, the coded structure of theinner portion 28 of the retaining member 26 is defined by a color codingof red. Therefore, when the lancet assembly 10 is in the protectedposition of FIG. 4 the color coding red is observable on the shaft 29,through the space 50, as well as on the inner portion 28 of theretaining member 26, as through the one or more windows 52. Therefore,in the protected position of the lancet 12 and penetrating tip 14, asshown in FIG. 4, the predominantly observable color coding is red andprovides a clearly alert or danger indication that the lancet assembly10 has been previously used.

[0053] It is also emphasized that the term “predominantly observable” isnot necessarily indicative of which of the plurality of color codings,green, yellow or red, is most present. To the contrary, in the protectedposition of FIG. 4, the fact that the color coding of the shaft 29 andinterior portion 28 is red and becomes observable as the lancet 12 andtip 14 is positioned in the protected position serves to define it asthe predominantly observable color coding. An observer is therebyprovided with a clear indication of an alert or even danger condition tothe extent that the lancet assembly 10 has been previously used andshould not be adjusted or otherwise manipulated to attempt re-use.

[0054] It is therefore seen that the coded structures may be defined bya plurality of color codings to the extent that at least some or all ofthe cover member 16, the protective member 22, and the retaining member26 may have at least one color codings thereon. As explained above, theretaining member 26 has more than one color coding defining the codedstructures, wherein the inner portion 28 and shaft 29 is red and theouter and/or barrel portion 26, 30, is green.

[0055] Yet another preferred embodiment as shown in FIGS. 5 and 6,wherein the lancet assembly 10′ has an almost identical structure withthe exception of a modification of the aforementioned coupling assembly.In addition, the additional preferred embodiment of FIGS. 5 and 6includes a coded structure including a plurality of color codings asdescribed in detailed reference to the embodiment of the FIGS. 1 through4.

[0056] More specifically, the lancet assembly 10′ includes a lancet 12including a penetrating tip 14 and an elongated sleeve or shaft 29which, as set forth above, may be considered part of the retainingmember 26 or the lancet 12, itself. Similarly, the lancet assembly 10includes a protective member 22 selectively positionable relative to thelancet 12 and shaft 29 so as to be positionable in the protectedposition referred to above and describe in detailed with specificreference to FIG. 4. In addition, the protected member 22 includes atleast one but preferable a plurality of elongated arms 34 movable withinthe opening or space 32 which serves to separate the inner portion 28 ofthe retaining member 26 from the outer or barrel portion 30.

[0057] However, one structural modification included in the additionalpreferred embodiment of FIGS. 5 and 6 is the coupling assembly includingtwo receiving recesses or slots 38′ and 38″ correspondingly positionedto receive a coupling head 36 of a respective of the arms 34. As isevident, the recesses or slot 38′ has a significantly largerlongitudinal dimension than that of the slot 38′. This dimension allowsmovement of a respective one of the coupling heads 36, associated arm 34and protective member 32 in a longitudinal direction relative to thelancet 12 and shaft 29, while the coupling head 36 is maintained withinthe enlarged slot or recess 38″. In addition, the preferred embodimentof FIGS. 5 an 6 also includes a biasing assembly 60 disposed betweeninterior surfaces 22′ and 28′ of the protective member 22 and the innerportion 28 of the retaining member 26.

[0058] The biasing assembly 60 may take a variety of differentstructural configurations such as, but not limited to a biasing memberhaving a somewhat coiled or other configuration having opposite endsengaging the aforementioned surfaces 22′ and 28′. In such a positionedthe biasing assembly 60 serves to normally biased or force theprotective member 22 outwardly, away from the inner portion 28 of theretaining member 26 while maintaining each of the one or more couplingheads 36 within the enlarged recess or slot 38″. In addition, thebiasing force exerted on the protective member 22, as shown in FIG. 5,will serve to position the protective member in surrounding protectingposition relative to the penetrating tip 14.

[0059] However, it is emphasized that the operative position of FIG. 5defines an operative position of the lancet 12 and penetrating 14 inthat the lancet assembly 10′ has not been used but is in a positionwhich is assumed when the lancet assembly 10′ is removed from itspackaging and a cover member 16, when utilized, has been removed.

[0060] Another feature of the embodiment of FIGS. 5 and 6 is thestructuring or configuring of the biasing assembly 60 to generatesufficient force to normally biased the protective member 22 in theoutwardly oriented position as shown in FIG. 5. However, the biasingmember 60 is such as to relatively easily allow the protective member 22to be forced into the position of FIG. 6 in order to clearly expose thepenetrating tip 14, for use on the patient in the intended manner. Thepositioning of the protective member 22 can be radially accomplish usinga mechanical triggering device, as discussed above, or by merely placingthe outer most end 22″, while the lancet assembly 10′ is in the positionof FIG. 5, in physical contact with the skin of the patient. When sopositioned a pushing force exerted on the retaining member 26 willeasily allow for the exiting and exposure of the penetrating tip 14outwardly through the open end 27 of the interior channel 25 and intopenetrating relation to the patient. Therefore, the biasing forceexerted by the biasing assembly 60 can be radially overcome when it isintended to use the lancet assembly 10′.

[0061] Accordingly, the lancet assembly 10′ may also be defined asincluding an operative position which is more specifically described asincluding a non-exposed tip position as represented in FIG. 5 and anexposed tip position as represented in FIG. 6. The length or increaseddimension of the recess 38″ is such as to freely allow movement of theprotective member 22 between the non-exposed tip position of FIG. 5 andthe exposed tip position of FIG. 6 so as to be operative in the intendedfashion, as described above.

[0062] After use, the lancet assembly 10′ and more particularly thelancet 12 and penetrating tip 14 are selectively positioned into theprotected position of FIG. 4 by enforcing the protective member 22outwardly as represented by directional arrow 27 of FIG. 3 such that thecoupling heads 36 are lockingly received within corresponding ones ofthe recesses 38′.

[0063] As also represented in FIG. 5 viewing of the appropriatelypositioned coded structures may be accomplish through the openings orspacing 50 existing between the correspondingly disposed surfaces 22′and 28′ when the lancet assembly 10′ is in the operative, non-exposedtip position of FIG. 5 or in the protective position of FIG. 4.

[0064] Also it should be apparent that, regardless of which of the abovenoted preferred embodiments is utilized, visual exposure of the variouscoded structures, in sequence, is at least partially indicative of therelative orientations or a change in such relative orientations of theplurality of the members as they are selectively disposed in the variouspredetermined covered position, operative position and/or protectedposition.

[0065] Since many modifications, variations and changes in detail can bemade to the described preferred embodiment of the invention, it isintended that all matters in the foregoing description and shown in theaccompanying drawings be interpreted as illustrative and not in alimiting sense. Thus, the scope of the invention should be determined bythe appended claims and their legal equivalents.

[0066] Now that the invention has been described,

What is claimed is:
 1. A lancet assembly comprising: a) a lancet havinga penetrating tip formed on one end thereof, b) a plurality of membersdisposable relative to said lancet to define at least an operativeposition and a protected position of said lancet, and c) at least someof said plurality of members including a coded structure disposedthereon and being indicative of said lancet being at least in saidoperative position or said protected position.
 2. A lancet assembly asrecited in claim 1 wherein said plurality of members including saidcoded structures disposed thereon are structured to be visuallyindicative of a change in orientation of respective ones of saidplurality of members.
 3. A lancet assembly as recited in claim 2 whereinsaid coded structures of respective ones of said plurality of membersare disposed in a visually observable position or a visuallynon-observable position dependent on the orientation of said pluralityof members relative to said lancet.
 4. A lancet assembly as recited inclaim 1 wherein said coded structures comprise a plurality of colorcodlings at least some of which are visually distinguishable from oneanother.
 5. A lancet assembly as recited in claim 3 wherein said codedstructures comprise a plurality of indicia at least some of which aredistinguishable from one another.
 6. A lancet assembly as recited inclaim 1 wherein at least some of said plurality of members are movablerelative to said lancet to define said operative position and saidprotected position.
 7. A lancet assembly as recited in claim 6 whereinat least some of said plurality of members are selectively movablerelative to said lancet to further define a covered position of saidlancet.
 8. A lancet assembly as recited in claim 7 wherein said codedstructures on at least some of said plurality of members are disposedand structured to provide a visual indication of the relativeorientation of said plurality of members and said lancet being in saidoperative position, said protected position or said covered position. 9.A lancet assembly as recited in claim 8 wherein at least some of saidcoded structures are visually distinguishable from one another.
 10. Alancet assembly as recited in claim 9 wherein said coded structurescomprise a plurality of color codlings at least some of which arevisually distinguishable from one another.
 11. A lancet assembly asrecited in claim 9 wherein at least some of said coded structures arevisually indistinguishable from one another.
 12. A lancet assembly asrecited in claim 11 wherein said coded structures comprise a pluralityof color codlings at least some of which are visually distinguishablefrom one another.
 13. A lancet assembly as recited in claim 11 whereinsaid coded structures comprise a plurality of indicia.
 14. A lancetassembly comprising: a) a lancet having a penetrating tip formed on oneend thereof, b) a retaining member fixedly secured to said lancet inspaced relation to said penetrating tip, c) a protective member being atleast initially movable relative to said lancet and positionable betweenan operative position and a protected position, and d) a plurality ofcoded structures formed on said retaining member and said protectivemember and being indicative of said lancet being in at least saidoperative position or said protected position.
 15. A lancet assembly asrecited in claim 14 wherein said plurality of coded structures arestructured and disposed to provide a visual indication of said lancetbeing in said operative position or said protected position.
 16. Alancet assembly as recited in claim 15 wherein at least some of saidcoded structures are visually distinguishable from one another.
 17. Alancet assembly as recited in claim 16 wherein at least some of saidcoded structures are visually indistinguishable from one another.
 18. Alancet assembly as recited in claim 17 wherein at least one of saidretaining member or protective member includes said coded structuresthereon being both visually distinguishable and visuallyindistinguishable from others of said plurality of coded structures. 19.A lancet assembly as recited in claim 14 further comprising a covermember movably disposed relative to said lancet and positionable intoand out of a covered position.
 20. A lancet assembly as recited in claim19 wherein at least one of said plurality of coded structures is formedon said cover member, said one coded structure being at least partiallyindicative of said lancet being in said covered position.
 21. A lancetassembly as recited in claim 20 wherein said plurality of codedstructures comprise a plurality of color codings disposed on saidretaining member, said protective member and said cover member, saidplurality of color codings are disposed in either a substantiallyobservable position or a substantially non-observable position dependenton the relative orientation of said retaining member, said protectivemember and said cover member.
 22. A lancet assembly as recited in claim21 wherein one or more of said plurality of color codings disposed insaid observable positions being indicative of said lancet being in oneof said operative position, covered position or protected position. 23.A lancet assembly as recited in claim 22 wherein said covered positionis defined by said penetrating tip extending outwardly from saidprotective member and in enclosed relation by said cover member.
 24. Alancet assembly as recited in claim 23 wherein said covered position isfurther defined by color codings of both said cover member and saidretainer member being predominantly observable.
 25. A lancet assembly asrecited in claim 24 wherein said color codings of both said cover memberand said retainer member are substantially visually indistinguishable.26. A lancet assembly as recited in claim 22 wherein said operativeposition is defined by said penetrating tip extending outwardly fromsaid protective member in an exposed orientation.
 27. A lancet assemblyas recited in claim 26 wherein said operative position is furtherdefined by said color codings of said retaining member and saidprotective member being predominantly observable.
 28. A lancet assemblyas recited in claim 27 wherein said color codings of both said retainingmember and said protective member are visually distinguishable from oneanother.
 29. A lancet assembly as recited in claim 22 wherein saidprotected position is defined by said penetrating tip disposed in acovered, non-exposed orientation within said protective member.
 30. Alancet assembly as recited in claim 29 wherein said protected positionis further defined by said color codings of said retainer member andsaid protected member being predominantly observable and said retainermember including at least two color codings visually distinguishablefrom one another.
 31. A lancet assembly as recited in claim 30 whereinsaid color coding of said protective member is visually distinguishablefrom each of said at least two color codings of said retainer member.32. A lancet assembly comprising: a) a lancet including a penetratingtip formed on one end thereof, b) a retaining member fixedly secured tosaid lancet in spaced relation to said penetrating tip, c) a protectivemember being at least initially movable relative to said lancet andpositionable between an operative position and a protected position, d)a cover member movably disposed relative to said lancet and positionableinto and out of a covered position, e) each of said retaining member,protective member, and covered member including at least one codedstructure positionable in either a substantially observable or asubstantially non-observable position dependent on the orientation ofsaid protective member and said cover member relative to said lancet,and f) predominantly observable ones of said coded structures beingindicative of said lancet being disposed in said operative position,said covered position or said protected position.
 33. A lancet assemblyas recited in claim 32 wherein said coded structures comprise at leastone color coding disposed on each of said retaining member, saidprotective member and said cover member.
 34. A lancet assembly asrecited in claim 32 wherein said covered position is defined by saidpenetrating tip extending outwardly from said protective member and inenclosed relation by said cover member.
 35. A lancet assembly as recitedin claim 34 wherein said covered position is further defined by saidcoded structure of both said covered member and said retainer memberbeing predominantly observable.
 36. A lancet assembly as recited inclaim 35 wherein said coded structure of both said cover member and saidretainer member are substantially the same.
 37. A lancet assembly asrecited in claim 32 wherein said operative position is defined by saidpenetrating tip extending outwardly from said protective member in anexposed orientation.
 38. A lancet assembly as recited in claim 37wherein said operative position is further defined by said codedstructures of said retaining member and said protective member beingpredominantly observable.
 39. A lancet assembly as recited in claim 38wherein said coded structures of both said retaining member and saidprotective member are different.
 40. A lancet assembly as recited inclaim 32 wherein said protective position is defined by said penetratingtip disposed in a covered, non-exposed orientation within saidprotective member.
 41. A lancet assembly as recited in claim 40 whereinsaid protective position is further defined by said coded structures ofsaid retainer member and said protective member being predominantlyobservable; said retainer member including at least two coded structuresbeing visually distinguishable from one another; said coded structure ofsaid protective member being visually distinguishable from each of saidat least two coded structures of said retainer member.
 42. A lancetassembly as recited in claim 32 further comprising a coupling assemblydisposed at least partially on both said retainer member and saidprotective member and structured to fixedly dispose said protectivemember in said protected position.
 43. A lancelet assembly comprising:a) a lancet having a penetrating tip formed on one end thereof, b) aplurality of members disposable relative to said lancet to define aprotected position in at least two operative position of said lancet,and c) said two operative positions comprising a non-exposed tippositioned and an exposed tip positioned.
 44. A lancet assembly asrecited in claim 43 further comprising a biasing assembly disposed tonormally biased at least some of said plurality of members into one ofsaid non-exposed tip position or said exposed tip position.
 45. A lancetassembly as recited in claim 44 further comprising a coupling assemblyinterconnected between at least some of said plurality of members andstructured to fixedly orient said lancet in said protected position. 46.A lancet assembly as recited in claim 44 wherein said coupling assemblyis further structured to allow selective orientation of said lancetbetween said non-exposed tip position and said exposed tip position. 47.A lancet assembly as recited in claim 44 wherein said biasing assemblyis disposed to normally orient said lancet into said non-exposed tipposition; said biasing assembly structured to permit selectiveorientation of said lancet from said non-exposed tip position into saidexposed tip position.
 48. A lancet assembly as recited in claim 43wherein at least some of said plurality of members include a codedstructure disposed thereon and being indicative of said lancet being atleast in said protected position or at least one of said operativepositions.
 49. A lancet assembly as recited in claim 43 furthercomprising a coupling assembly interconnected between at least some ofsaid plurality of members and structured to selectively maintainorientation of said lancet in either said two operative positions orsaid protected position.
 50. A lancet assembly as recited in claim 49wherein said coupling assembly is structured to fixedly orient saidlancet in said protected position.
 51. A lancet assembly as recited inclaim 49 wherein said coupling assembly is further structured to allowselective orientation of said lancet between said non-exposed tipposition and said exposed tip position.
 52. A lancet assembly as recitedin claim 51 wherein at least some of said plurality of members include acoded structure disposed thereon and being indicative of said lancetbeing at least in said protected position or at least one of saidoperative positions.